Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

A randomised trial consisting of arms A and B. Both arms commence induction chemotherapy Day 1 Gemcitabine 1000mg/m2 + Carboplatin AUC 5 Day 8 Gemcitabine 1000mg/m2 Day 22 Gemcitabine 1000mg/m2 + Carboplatin AUC 5 Day 29 Gemcitabine 1000mg/m2 with Concurrent treatment, radiation and Gemcitabine treatment. Arm A will receive External beam radiation, 30 Gy/15 fractions/5 per week with Gemcitabine 200mg weekly with fractions days 43, 50 & 57 given 5 or more hours prior to the radiation. Arm B will receive External beam radiation, 30 Gy/15 fractions/5 per week with Gemcitabine 200mg weekly with fractions days 43, 50 & 57 given within 3 hours or less prior to the radiation.

Query!

Intervention code [1]1900

Treatment: Drugs

Query!

Comparator / control treatment

Query!

Control group

Active

Query!

Outcomes

Primary outcome [1]3490

Objective response rate within the irradiated volume

Query!

Timepoint [1]3490

6 weeks post treatment and 3 monthly follow ups until death or loss to follow-up.

Query!

Secondary outcome [1]7880

1. Toxicity

Query!

Timepoint [1]7880

Query!

Secondary outcome [2]7890

2. Progression-free survival

Query!

Timepoint [2]7890

Query!

Secondary outcome [3]7900

3. Overall survival

Query!

Timepoint [3]7900

Query!

Eligibility

Key inclusion criteria

Histologically or cytologically proven non-small cell lung cancer.-Planned moderate dose radiation therapy for locoregional control. -Patients found to have a locally advanced thoracic disease suitable for radical therapy but on work up are found to have solitary metastasis. If in the brain the metastasis must be operable-Patients must have measurable disease on imaging scans.

Query!

Minimum age

Not stated

Query!

Query!

Maximum age

Not stated

Query!

Query!

Gender

Both males and females

Query!

Can healthy volunteers participate?

No

Query!

Key exclusion criteria

History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that cancer for at least 5 years.-Receiving treatment with another investigational agent.

Query!

Study design

Purpose of the study

Treatment

Query!

Allocation to intervention

Randomised controlled trial

Query!

Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures)

sealed envelopes

Query!

Methods used to generate the sequence in which subjects will be randomised (sequence
generation)

the sequencing was generated with Statview with a p value of .5 and n = 24